SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT

K053199 · Synthes (Usa) · GXN · Dec 14, 2005 · Neurology

Device Facts

• Record ID: K053199
• Device Name: SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
• Applicant: Synthes (Usa)
• Product Code: GXN · Neurology
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Device Story

Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) replaces bony voids in cranial/craniofacial skeleton; multi-piece implants preformed/pre-shaped to patient anatomy; sizes range 100x100 mm to 350x350 mm; attaches to native bone using standard Synthes cranial/craniofacial plates and screws (1.3 mm to 2.0 mm); manufactured from CP Titanium and PEEK; used by surgeons to restore cranial/craniofacial structure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: CP Titanium and PEEK. Fixation: Standard Synthes cranial/craniofacial plates and screws (1.3 mm to 2.0 mm). Form factor: Multi-piece, preformed/pre-shaped patient-specific implants. Dimensions: 100x100 mm to 350x350 mm.

Indications for Use

Indicated for patients requiring replacement of bony voids in the cranial and/or craniofacial skeleton.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• Synthes Patient Specific Cranial/Craniofacial Implant (K033868)
• Porex Medical: MEDPOR Porous Polyethylene Cranial Implants (K832283)

Submission Summary (Full Text)

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K053199 -______________________________________________________________________________________________________________________________________________________________________________

| 510(k) Summary | | Page 1 of 1 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] | |
| Device Name: | Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) | |
| Classification: | Class II § 21 CFR 882.5330: Plate, Cranioplasty, preformed, non-alterable | |
| Predicate Devices: | Synthes Patient Specific Cranial/Craniofacial Implant,<br>K033868<br>Porex Medical: MEDPOR Porous Polyethylene Cranial<br>Implants, K832283 | |
| Device Description: | The Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) replaces bony voids in the cranial/craniofacial skeleton. Multi-piece implants are preformed / pre-shaped to fit the anatomy of the patient, will range in size from 100 x 100 mm to 350 x 350 mm, and attach to the native bone using standard Synthes cranial and craniofacial plates and screws in sizes 1.3 mm through 2.0 mm. The Synthes Patient Specific Cranial/Craniofacial Implants are manufactured from CP Titanium and PEEK. | |
| Intended Use: | Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial/craniofacial skeleton | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2005

Ms. Kathleen Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K053199

Trade/Device Name: Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: November 15, 2005 Received: November 16, 2005

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kathleen Anderson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace gacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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ﮐﮯ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 2.0 | Indications for Use |
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| 510(k) Number (if known): | K05 3199 |
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| Device Name: | Synthes (USA) Patient Specific Cranial/Craniofacial Implant |
| Indications for Use: | |

Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Prescription Use X AND/OR (Per 21 CFR 801.109)

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K053199

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